Z-0903-04

Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics

Name: Z-0903-04 Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics
Creator: Respironics California Inc
Published: 2001-06-01
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2001-06-01 / Terminated / root cause: software

FDA source

Respironics California Inc began a recall of Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics on 2001-06-01. The reason FDA records is "Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0903-04
Status: Terminated
Initiated: 2001-06-01
Posted: 2004-07-20
Terminated: 2004-05-12
Recalling firm: Respironics, Inc.
Product: Espirit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.
Root cause tag: software
FDA root cause: Other
Action: Firm technicians and foreign representatives were responsible for updating software on or about 6/1/01.
Quantity in commerce: 749
Distribution: Nationwide, Argentina, Brazil, Canada, China, Chile, Egypt, India, Italy, Japan, Korea, Mexico, Pakistan, Panama, Philipines, Puerto Rico, Singapore, Spain, Thailand, Turkey, Vietnam.
Product codes and lots: All Codes.

Product code CBK

K981072Class IIEsprit VentilatorRespironics, Inc. / cleared 1998-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)